FDA approves new labeling saying Vytorin outperformed Crestor in study
Merck and Schering Plough last week won FDA approval to include new product labeling saying Vytorin is better at lowering bad cholesterol than competitor, AstraZeneca’s Crestor.
The approval follows a Merck/Schering-Plough study of nearly 3,000 patients that found Vytorin lowered bad cholesterol by an average of 52% to 61% across doses, compared with 42% to 57% in the Crestor dosing group.
Vytorin and Crestor battle for market share in the $30 billion-a-year cholesterol lowering drug market.
Mike Tilton, VP, cardiovascular for AstraZeneca, told Delaware newspaper The News Journal that the labeling change won't cut into Crestor sales, which have been growing at a rapid pace this year despite the fact that Merck and Schering released the results of their clinical trial 10 months ago.
AstraZeneca has its own clinical data showing that a combination of Crestor and Zetia produced a 70% reduction in LDL cholesterol, the biggest decrease of any statin, the company said.
Crestor “is one of the most effective treatments for lowering LDL cholesterol and will continue to be an important monotherapy option for patients with elevated cholesterol,” AstraZeneca said in a statement.